Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.

Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Abstract

Optimal candidates for VNS as a treatment for refractory epilepsy have not been identified. In this retrospective two-center study, we used the Engel classification for evaluating seizure outcome, and tried to identify predictive factors for outcome by means of subgroup analysis. The medical records of patients who have been treated with VNS for at least one year at Dartmouth-Hitchcock Medical Center and Ghent University Hospital were evaluated. Seizure frequency outcome was assessed using the Engel classification for the study population as a whole, and for patient subgroups with regard to mental functioning, seizure type, predisposing factors for developing epilepsy, age at time of VNS implantation and epilepsy duration. 189 patients (102M/87F) were included in the study (mean FU: 41 months). 6% had a class I outcome (seizure-free), 13% a class II outcome (almost seizure-free), 49% a class III outcome (worthwhile improvement) and 32% had a class IV outcome (no improvement).

When patients were divided into specific subgroups, a statistically significant better outcome was found patients with normal mental functioning (p=0.029). In our series, results for VNS are clearly inferior to resective surgery, but comparable to other treatment modalities for refractory epilepsy. With combined class I and II outcomes around 20%, and another 50% of patients having worthwhile improvement, VNS is a viable alternative when resective surgery is not feasible.

Monday, January 24, 2011

Why Almost Everything You Hear About Medicine Is Wrong

If you follow the news about health research, you risk whiplash. First garlic
lowers bad cholesterol, then—after more study—it doesn’t. Hormone replacement
reduces the risk of heart disease in postmenopausal women, until a huge study
finds that it doesn’t (and that it raises the risk of breast cancer to boot).
Eating a big breakfast cuts your total daily calories, or not—as a study
released last week finds. Yet even if biomedical research can be a fickle guide,
we rely on it.

But what if wrong answers aren’t the exception but the rule? More and more
scholars who scrutinize health research are now making that claim. It isn’t just
an individual study here and there that’s flawed, they charge. Instead, the very
framework of medical investigation may be off-kilter, leading time and again to
findings that are at best unproved and at worst dangerously wrong. The result is
a system that leads patients and physicians astray—spurring often costly
regimens that won’t help and may even harm you.

It’s a disturbing view, with huge im-plications for doctors, policymakers,
and health-conscious consumers. And one of its foremost advocates, Dr. John P.A.

Ioannidis, has just ascended to a new, prominent platform after years of
crusading against the baseless health and medical claims. As the new chief of
Stanford University’s Prevention Research Center, Ioannidis is cementing his
role as one of medicine’s top mythbusters. “People are being hurt and even
dying” because of false medical claims, he says: not quackery, but errors in
medical research.

This is Ioannidis’s moment. As medical costs hamper the economy and impede
deficit-reduction efforts, policymakers and businesses are desperate to cut them
without sacrificing sick people. One no-brainer solution is to use and pay for
only treatments that work. But if Ioannidis is right, most biomedical studies
are wrong.

In just the last two months, two pillars of preventive medicine fell. A major
study concluded there’s no good evidence that statins (drugs like Lipitor and
Crestor) help people with no history of heart disease. The study, by the
Cochrane Collaboration, a global consortium of biomedical experts, was based on
an evaluation of 14 individual trials with 34,272 patients. Cost of statins:
more than $20 billion per year, of which half may be unnecessary. (Pfizer, which
makes Lipitor, responds in part that “managing cardiovascular disease risk
factors is complicated”). In November a panel of the Institute of Medicine
concluded that having a blood test for vitamin D is pointless: almost everyone
has enough D for bone health (20 nanograms per milliliter) without taking
supplements or calcium pills. Cost of vitamin D: $425 million per
year.

Ioannidis, 45, didn’t set out to slay medical myths. A child prodigy (he was
calculating decimals at age 3 and wrote a book of poetry at 8), he graduated
first in his class from the University of Athens Medical School, did a residency
at Harvard, oversaw AIDS clinical trials at the National Institutes of Health in
the mid-1990s, and chaired the department of epidemiology at Greece’s University
of Ioannina School of Medicine. But at NIH Ioannidis had an epiphany. “Positive”
drug trials, which find that a treatment is effective, and “negative” trials, in
which a drug fails, take the same amount of time to conduct. “But negative
trials took an extra two to four years to be published,” he noticed. “Negative
results sit in a file drawer, or the trial keeps going in hopes the results turn
positive.” With billions of dollars on the line, companies are loath to declare
a new drug ineffective. As a result of the lag in publishing negative studies,
patients receive a treatment that is actually ineffective. That made Ioannidis
wonder, how many biomedical studies are wrong?

His answer, in a 2005 paper: “the majority.” From clinical trials of new
drugs to cutting-edge genetics, biomedical research is riddled with incorrect
findings, he argued. Ioannidis deployed an abstruse mathematical argument to
prove this, which some critics have questioned. “I do agree that many claims are
far more tenuous than is generally appreciated, but to ‘prove’ that most are
false, in all areas of medicine, one needs a different statistical model and
more empirical evidence than Ioannidis uses,” says biostatistician Steven
Goodman of Johns Hopkins, who worries that the most-research-is-wrong claim
“could promote an unhealthy skepticism about medical research, which is being
used to fuel anti-science fervor.”

Even a cursory glance at medical journals shows that once heralded studies
keep falling by the wayside. Two 1993 studies concluded that vitamin E prevents
cardiovascular disease; that claim was overturned by more rigorous experiments,
in 1996 and 2000. A 1996 study concluding that estrogen therapy reduces older
women’s risk of Alzheimer’s was overturned in 2004. Numerous studies concluding
that popular antidepressants work by altering brain chemistry have now been
contradicted (the drugs help with mild and moderate depression, when they work
at all, through a placebo effect), as has research claiming that early cancer
detection (through, say, PSA tests) invariably saves lives. The list goes
on.

Despite the explosive nature of his charges, Ioannidis has collaborated with
some 1,500 other scientists, and Stanford, epitome of the establishment, hired
him in August to run the preventive-medicine center. “The core of medicine is
getting evidence that guides decision making for patients and doctors,” says
Ralph Horwitz, chairman of the department of medicine at Stanford. “John has
been the foremost innovative thinker about biomedical evidence, so he was a
natural for us.”

Ioannidis’s first targets were shoddy statistics used in early genome
studies. Scientists would test one or a few genes at a time for links to
virtually every disease they could think of. That just about ensured they would
get “hits” by chance alone. When he began marching through the genetics
literature, it was like Sherman laying waste to Georgia: most of these candidate
genes could not be verified. The claim that variants of the vitamin D–receptor
gene explain three quarters of the risk of osteoporosis? Wrong, he and
colleagues proved in 2006: the variants have no effect on osteoporosis. That
scores of genes identified by the National Human Genome Research Institute can
be used to predict cardiovascular disease? No (2009). That six gene variants
raise the risk of Parkinson’s disease? No (2010). Yet claims that gene X raises
the risk of disease Y contaminate the scientific literature, affecting personal
health decisions and sustaining the personal genome-testing
industry.

Statistical flukes also plague epidemiology, in which researchers look for
links between health and the environment, including how people behave and what
they eat. A study might ask whether coffee raises the risk of joint pain, or
headaches, or gallbladder disease, or hundreds of other ills. “When you do
thousands of tests, statistics says you’ll have some false winners,” says
Ioannidis. Drug companies make a mint on such dicey statistics. By testing an
approved drug for other uses, they get hits by chance, “and doctors use that as
the basis to prescribe the drug for this new use. I think that’s wrong.” Even
when a claim is disproved, it hangs around like a deadbeat renter you can’t
evict. Years after the claim that vitamin E prevents heart disease had been
overturned, half the scientific papers mentioning it cast it as true, Ioannidis
found in 2007.

The situation isn’t hopeless. Geneticists have mostly mended their ways,
tightening statistical criteria, but other fields still need to clean house,
Ioannidis says. Surgical practices, for instance, have not been tested to nearly
the extent that medications have. “I wouldn’t be surprised if a large proportion
of surgical practice is based on thin air, and [claims for effectiveness] would
evaporate if we studied them closely,” Ioannidis says. That would also save
billions of dollars. George Lundberg, former editor of The Journal of the
American Medical Association, estimates that strictly applying criteria like
Ioannidis pushes would save $700 billion to $1 trillion a year in U.S.
health-care spending.

Of course, not all conventional health wisdom is wrong. Smoking kills, being
morbidly obese or severely underweight makes you more likely to die before your
time, processed meat raises the risk of some cancers, and controlling blood
pressure reduces the risk of stroke. The upshot for consumers: medical wisdom
that has stood the test of time—and large, randomized, controlled trials—is more
likely to be right than the latest news flash about a single food or
drug.

The following article I found of much interest and I’d quickly like to share my viewpoint. I am very much in favor of most all treatment options for depression with the understanding that I endorse patient and/or support person education to make reasonably informed and un-coerced medical decisions in collaboration with one’s trusted, caring, knowledgeable and licensed health care practitioner.

In this instance I agree to downgrade the risk classification of electroshock devices with an important proviso:

F.D.A. Is Studying the Risk of Electroshock Devices

Federal regulators are weighing whether to downgrade the risk classification of electroshock devices, reinforcing what many psychiatrists consider a deepening acceptance of electroshock in modern therapy.

The procedure has had a resurgence in recent years. And an estimated 100,000 Americans — two-thirds of them women — undergo the treatment for major depression and other illnesses each year. Patients, anesthetized, receive a jolt of electricity from electrodes for several seconds, inducing a brain seizure and convulsions of up to a minute.

To some extent, the review has renewed the debate over electroshock. In 1990, F.D.A. staff proposed declaring the devices safe for major depression, but never took final action amid an uproar by opponents.

If the F.D.A. downgrades the devices to a medium-risk category, the equipment could be promoted and sold without new testing. Such a downgrade would place the devices in the same risk category as syringes and surgical drills.

If the F.D.A. leaves the devices in the high-risk category, however, manufacturers may, depending on the agency, have to withdraw them from the market.

The F.D.A. could require safety and effectiveness tests that have not previously been done. By regulating the devices, the F.D.A. is indirectly regulating the procedure.

The agency could make a formal decision later this year. The F.D.A. usually, but not always, follows recommendations of its advisory panels.

Supporters, including mainstream psychiatrists, say the treatment is much safer than it once was and could pass a rigorous F.D.A. review. But they assert that the device manufacturers cannot afford those tests.

“These tend to be mom-and-pop operations,” said Dr. Matthew V. Rudorfer, a psychiatrist and top specialist at the National Institute of Mental Health. “So I think the dilemma might be that undergoing new expensive clinical trials might be too expensive.”

Opponents, including some groups of former patients, maintain that electroshock can cause memory loss and brain damage that outweigh its short-term benefits.

“It’s all trial and error — it’s all experimental,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York. “All the years it’s been controversial and there have not been clinical trials. Why not?”

Only two manufacturers, Somatics L.L.C. of Lake Bluff, Ill., and the Mecta Corporation of Lake Oswego, Ore., make the devices in the United States. The F.D.A. has asked them to submit all safety and effectiveness information as part of an agency review to be released before the advisory committee meeting beginning on Thursday.

Dr. Richard Abrams, who founded Somatics in 1983 with Dr. Conrad M. Swartz, and has written a textbook on electroshock, wrote the F.D.A. to say that none of his patients in more than 10,000 sessions over three decades had reported prolonged memory loss.

Dr. Swartz, who, like Dr. Abrams, is a retired psychiatry professor, said in an e-mail that any cognitive side effects from Somatics’ latest device “are distinctly less than they had been.” But he said Somatics could not afford an in-depth safety study that the F.D.A. could require if it left the devices in the high-risk category. That could cost millions of dollars.

“There is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature,” Dr. Swartz wrote.

Mecta would not comment. “We always get negative press,” said a woman who answered the telephone at the company’s headquarters and did not give her name. “Too bad, because it’s good equipment.”

Somatics and Mecta each have annual revenue exceeding $1 million, according to Dun & Bradstreet. Dr. Swartz, asked about the revenue figure, said Somatics, like Mecta, was a private company. Their Web sites do not list prices or sales figures.

More than 1,000 hospitals and outpatient clinics in the United States use the two companies’ devices, according to Dr. Charles H. Kellner, a leading researcher, professor and chief of geriatric psychiatry at Mount Sinai School of Medicine in New York.

“It’s a treatment for the most severe form of depression,” Dr. Kellner said. “It can really be life-saving.”

The F.D.A. review was recommended by the Government Accountability Office in 2009 as part of an examination of the regulatory status of electroshock and about 20 other less controversial medical devices, like pacemaker electrodes and implanted blood access devices for hemodialysis. They were grandfathered into F.D.A. regulations when the agency was given more authority over medical devices in 1976.

The G.A.O. said those devices should go through the stringent approval process for high-risk devices or be reclassified as medium or low risk. A medium-risk designation could include adding controls like performance standards and patient registries.

The treatment costs $1,000 to $2,500 a session, and typically involves three sessions a week for two to four weeks, Dr. Kellner said. The fee includes the services of a psychiatrist and anesthesiologist. The equipment itself costs about $15,000 and may last years.

Patients are given short-term full anesthesia, a powerful muscle relaxant to prevent pain and subdue convulsions, and a mouth guard. The electrical current causes a grand mal seizure with convulsions usually lasting less than a minute, doctors say. Five to 10 minutes later, the patient awakens and can usually go home within two hours.

A federally financed study in 2007 found long-term memory loss and other cognitive problems, especially for female patients, from the treatment at seven New York facilities. The study, of 347 patients, was the first such large-scale study of side effects, despite what its authors called “over 50 years of clinical use and ongoing controversy.” The study also said methods and voltage varied widely among practitioners.

Dr. Rudorfer, associate director of treatment research in a division of the National Institute of Mental Health, says modern electroconvulsive therapy, or E.C.T., as its supporters prefer to call it, is much better than earlier practices, like those portrayed in “One Flew Over the Cuckoo’s Nest.”

“As surprising as it might seem, it never went away,” Dr. Rudorfer said of the treatment. “The field has had ample opportunity to get rid of E.C.T. and it’s still with us because it seems to occupy a small but important niche in treatment.”

But Dr. Rudorfer and other scientists still do not know just how the treatment or brain seizures act to improve moods. “We’re still looking,” he said. “It’s been very difficult to tease out the ‘active ingredient’ from among the many changes in the brain that accompany having, and stopping, the therapeutic seizure activity.”

Patients appear to have mixed views, judging from comments to the F.D.A. and electroshock-related Web sites. Some say it saved their lives, some say they suffered too much memory loss, and some say both.

In addition to its use in cases of severe depression, the treatment is used in some cases where speed is essential, like psychosis or suicidal behavior, for catatonia and in elderly patients who take so many other drugs that they cannot safely add a powerful psychiatric drug.

Dr. James H. Scully Jr., medical director and chief executive of the American Psychiatric Association, wrote the F.D.A. recently to say the treatment was “extremely effective and safe.” It provides relief some 80 percent of the time, he wrote. Dr. Scully and the psychiatry association also say there is no evidence it causes brain damage.

A task force is updating the association’s 2001 recommendations on the treatment. Its report is at least a year away.

“These disorders can be extremely life-threatening, and when it works, it can be dramatically effective,” she said.

Opponents of electroshock include some patient advocacy groups, but the opponents, clearly, are outnumbered among physicians.

Dr. Peter R. Breggin, author of more than a dozen books including one about electroshock and a consultant in personal injury cases involving drugs and the therapy, says he is the only American psychiatrist he knows who opposes the treatment.

“It’s a big money-maker,” he said. “I would say if anything it’s been on the increase because there’s a market that’s been exploited, that is the elderly depressed women on Medicare. The reason for that is they’re covered, and there’s no one to protect them. What commonly stops shock treatment is a family member saying ‘over my dead body.’ ”

Depressed older people, Dr. Breggin said, can be helped more by a pet or conversation.

Last year, two psychology professors, John Read of the University of Auckland, New Zealand, and Richard Bentall of Bangor University, Wales, criticized electroshock after reviewing studies comparing it with simulated treatment. Their findings were published in Epidemiologia e Psichiatria Sociale, a peer-reviewed European psychiatric journal. “The cost-benefit analysis is so poor that its use cannot be scientifically justified,” Dr. Read wrote in an e-mail.

John Breeding, a psychologist and member of the Coalition for Abolition of Electroshock in Texas, said that state had banned electroshock for youths under 16 and required second opinions for treating the elderly, giving it the strictest rules in the nation.

“It’s a very strong treatment for despair and hopelessness,” he said. “It’s a temporary blunting of your feelings, so you feel better for a while, then you feel worse, and now you’ve got the memory loss and brain damage.”

University of South Florida, Department of Neurosurgery, Tampa, FL, United States.

Abstract

OBJECTIVE: Adequate control of intractable epilepsy continues to be a challenge. Little is known about the role of VNS therapy in intractable epilepsy in patients who failed to respond to surgical management. The objective of the present study is to determine the efficacy of vagus nerve stimulation therapy in patients with intractable epilepsy who have failed surgical and medical therapy.

METHODS: All the patients who had persistent seizures after cranial surgery who subsequently underwent vagus nerve stimulator (VNS) placement at our institution from 1998 to 2008 were included in the study. Thirty-seven consecutive patients were enrolled and followed for the outcome measures of seizure burden, anti-epileptic drug (AED) burden and quality of life (QoL). Minimum follow-up was 18 months.

RESULTS: Overall, 24 (64.9%), 9 (24.3%), 4 (10.8%) patients reported less than 30%, between 30% and 60% and greater than 60% reduction in seizure frequency after VNS placement, respectively at a mean of 5 years follow-up period. Post-VNS anti-epileptic requirement exhibited a decreasing trend. 17 patients (45.9%) report an improvement in QoL (better or much better).

CONCLUSION: VNS therapy in patients who have failed medical and surgical therapies only provides marginal improvement in seizure control but has greater likelihood to improve subjective QoL issues. In addition, VNS has the potential to reduce AED burden without adversely impacting seizure management. Given the low surgical risk of VNS placement, vagus nerve stimulation as a therapeutic modality should be individualized to achieve best clinical response and fewest side effects.

About Me

I'm a very, very long-time support person and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.